Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084115
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/09/1974 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-108 Labeling-Package Insert

Label is not available on this site.

08/29/2016 SUPPL-107 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/13/2011 SUPPL-103 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-100 Labeling-Package Insert

Label is not available on this site.

08/24/2009 SUPPL-97 Labeling

Label is not available on this site.

11/19/2008 SUPPL-94 Labeling

Label is not available on this site.

11/25/2002 SUPPL-79 Labeling

Label is not available on this site.

03/22/1999 SUPPL-78 Labeling

Label is not available on this site.

03/22/1999 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

09/16/1992 SUPPL-75 Labeling

Label is not available on this site.

12/31/1991 SUPPL-74 Labeling

Label is not available on this site.

11/29/1990 SUPPL-73 Labeling

Label is not available on this site.

04/14/1989 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

04/26/1988 SUPPL-71 Labeling

Label is not available on this site.

07/05/1988 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/08/1988 SUPPL-69 Labeling

Label is not available on this site.

04/14/1988 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

12/08/1987 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

09/05/1986 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

07/10/1986 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/26/1985 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/26/1985 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

04/26/1982 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/11/1982 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 209755 AMNEAL PHARMS CO
CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB 084115 UPSHER SMITH LABS

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